Evaluate the Frequency of Fatigue After Cerebral Infarction (Fatigue AVC)

December 5, 2022 updated by: Centre Hospitalier Universitaire Dijon

Fatigue After Stroke

Cerebral infarction is a type of stroke that can lead to sometimes disabling sequelae. Among these sequelae, fatigue is frequently reported by patients. It is therefore important for doctors to understand why patients suffer from fatigue after cerebral infarction and to determine whether treatments given for the cerebral infarction may have an impact on this fatigue.

The aim of this research was to study the frequency of fatigue after cerebral infarction, the associated factors, in particular the impact of treatments administered in the acute phase.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with cerebral infarction dating back one week at most

Description

Inclusion Criteria:

  • Patients presenting recent symptomatic cerebral infarction (< 1 week) defined according to World Health Organization (WHO) criteria and hospitalised at the Stroke Unit in Dijon University.
  • Patients aged 18 years or older.
  • Patients who have been informed about the study, or their person of trust for patients unable to express their consent.

Exclusion Criteria:

  • Patients (or their person of trust) who refuse to participate in the study.
  • Subjects in custody.
  • Patients presenting prior co-morbidity as a cause of significant fatigue in the opinion of the investigator
  • Patients with dementia or aphasia before the stroke
  • Patients (or their person of trust) who may be difficult to contact by telephone during the follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treated
Other: FSS: Fatigue Severity Scale
Fatigue scale with 9 items rated from 1 to 7, assessing physical fatigue, fatigue in the psychosocial environment and fatigue in general (3 items in each category).
Other: Neuropsychological evaluation battery
A standardized French neuropsychological battery for the cognitive evaluation of stroke patients.
Other: Other functional scores
Rankin Score, Instrumental Activities of Daily Living (IADL) Score, Rivermead Mobility Index (RMI) scale, Hospital Anxiety Depression scale (HAD) scale for depression / anxiety, Stroke Specific Quality of Life scale for quality of life, Quality Index of Pittsburgh Sleep (PSQI), Vertical Analog Visual Scale for Pain and Vertical Digital Visual Scale
Non-treated
Other: FSS: Fatigue Severity Scale
Fatigue scale with 9 items rated from 1 to 7, assessing physical fatigue, fatigue in the psychosocial environment and fatigue in general (3 items in each category).
Other: Neuropsychological evaluation battery
A standardized French neuropsychological battery for the cognitive evaluation of stroke patients.
Other: Other functional scores
Rankin Score, Instrumental Activities of Daily Living (IADL) Score, Rivermead Mobility Index (RMI) scale, Hospital Anxiety Depression scale (HAD) scale for depression / anxiety, Stroke Specific Quality of Life scale for quality of life, Quality Index of Pittsburgh Sleep (PSQI), Vertical Analog Visual Scale for Pain and Vertical Digital Visual Scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatigue evaluated using the Fatigue Severity Scale (FSS)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2017

Primary Completion (Actual)

November 22, 2018

Study Completion (Actual)

November 22, 2018

Study Registration Dates

First Submitted

September 18, 2017

First Submitted That Met QC Criteria

September 18, 2017

First Posted (Actual)

September 19, 2017

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Béjot 2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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